For companies that do not yet have DCT, we evaluate the benefits and risks of decentralization to give our clients a clear picture of what it means to run clinical programs virtually with the patient at the forefront under a culture of quality. We align on the desired point of arrival, short- and long-term goals, and assumptions. We deliver a business case with a value proposition that can be presented to executive stakeholders for endorsement and alignment.

Whether your company is starting from scratch or adapting an existing trial, we incorporate Quality by Design (QbD) recommendations and facilitate design sessions with key stakeholders to drive efficiency in trial design and increase the value to the patient, caregiver, and site. These design sessions may be run at the company, portfolio, or protocol level depending on the organization’s goals. Together we generate implementation scenarios including digital endpoint assessments, patient outcome measures, and decentralized trial options. We assess our clients’ current technology, process, and resources to determine which tools, skill sets, and third-party vendors are best suited for the implemented solution.

Our deliverables can include:

• Executive summary outlining options and the change impact assessment for decentralization
• Implementation plan across technology, process, and resourcing:
• Prioritized set of activities and timelines
• Process and document recommendations
• Resourcing recommendations (internal and external)
• DCT vendor recommendations
• CRO and DCT vendor integration and alignment
• Change management & training strategies
• Transition plans

Selecting the right decentralized clinical trial (DCT) vendor, who also integrates well with your CRO, and negotiating the optimal terms of the engagement is critical to the timely completion of a high-quality study for the lowest cost. We start with our proprietary network of DCT vendors that have passed our pre-verification and subject matter expert reviewal process.  

We recommend the appropriate DCT vendor for our clients’ unique needs based on the vendor’s ability to meet study criteria, provide uniform specifications to facilitate apples-to-apples comparisons, and critically review budgets, experience requirements, data solutions and technology infrastructure, and other factors on a qualitative and quantitative manner. We assist our clients in budget and scope negotiations that help them avoid future change orders or surprises and we incorporate risk sharing incentives and penalties wherever possible.

After selection, we often provide continued oversight and management of the DCT vendors ensuring the integration, communication, and effectiveness of vendors are consistently maintained throughout the course of the trial.

We partner with our clients to implement the technologies, processes, and resources necessary to create meaningful change for their organizations. We follow a strategic change management methodology, incorporating program leadership, role alignment, training and communication plans, and process documents where needed. We leverage our pre-qualified vendor shortlist to optimize execution.

Our deliverables include:

• Program leadership and governance
• Change management (Role alignment, RACI, Workflows, Sustaining governance)
• Virtualization implementation playbook
• Selected and qualified vendors
• Training and communication plans encompassing the sponsor, site, and patient levels
• Process documents
• Data integration plan including alignment of master data standards (if applicable)
• System implementation including validation support, data migration, training, and hypercare
• Study-specific implementation planning

We provide compliant, flexible virtual study management oversight, resources, and training to fit our clients’ trial needs.  We bring extensive third-party vendor selection and management experience as well as a breadth of regulatory, quality, and clinical expertise to help clients identify the right vendor match, deliver studies faster than traditional CROs, and provide the oversight required to obtain high quality study results. We provide comprehensive training at the sponsor, vendor, site, and patient-levels to ensure optimal study success.

We work with our clients to align key stakeholders on the importance of harnessing and managing their data. We work with senior leadership to outline an enterprise end-to-end data strategy that includes establishing Master Data Management (MDM) governance and processes, data quality best practices, a digital endpoint strategy, stakeholder reporting governance, and continuous improvement actions based on data insights.

Our deliverables include:

• Data Literacy Training
• MDM Strategy Development
• Data Governance Framework (processes, communication channels, roles and responsibilities, accountabilities, and escalation)
• Data Migration and Integration Plans
• Streamlined System and Report Inventory with Gap Assessment
• Data Standards and Data Dictionary

We work with our clients to turn their data into insights that drive action. Using industry benchmark data and data management strategies, we tailor our clients’ reporting needs to monitor key indicators of the operational health of their studies. We recognize that there are multiple data consumers that require different levels of information and will provide a suite of automated reports and/or dashboards that include industry standard metrics and benchmarks for performance such as:

• Portfolio-Level Senior Leadership Reporting (high-level operational, quality and financial health via established KPIs, KQIs and KRIs)
• Program-Level Management Reports
• Study-Level Management Reports
• Investigator/Site-Level Reporting (comparing individual site metrics to study medians)
• Patient-Level Reporting (providing visibility into collected health information)

We combine leading and lagging indicators coupled with embedded industry performance benchmarks so clients can set clearly defined targets to measure operational and clinical data health.   

We work with our clients to define the right technology-enabled risk management processes, key risk indicators (KRIs), quality tolerance limits (QTLs), and assessment/categorization tools that enable risk-based approaches across the company, program, and study levels. These processes allow for earlier detection and mitigation of risks, proactive decision making, and cost-saving operational efficiencies.

At the sponsor, program, and/or study level, we perform a risk assessment with the key stakeholders and vendors to identify the critical risks, thresholds, and mitigations for the clinical trials and new virtual options using an efficient, pre-configured risk assessment and categorization tool (RACT). We outline the risk management strategy and clear risk triage and communication processes in an integrated quality and risk management plan (IQRMP) and update functional plans as needed. We also develop and implement a risk-based monitoring (RBM) strategy/framework that fits into the risk management process.

Our deliverables include:

• Integrated Quality and Risk Management Plan (IQRMP)
• Risk Assessment and Categorization Tool (RACT) alignment across all vendors and stakeholders
• Key Risk Indicator (KRI) Library development and customization per study
• Risk-Based Monitoring strategy and framework development and implementation support

Halloran facilitates virtual or on-site inspection and audit readiness engagements, helping to prepare our clients for anticipated regulatory inspections (FDA, EMA, MHRA, PDMA, CFDA), diligence by investors, or potential partner evaluations. These engagements include inspection readiness preparedness, mock inspections and audits, storyboard preparation, behavioral interview training, and coaching. Halloran also leads clients through the immediate remediation by authoring responses including strategies for remediation and developing corrective and preventative action plans (CAPA).